Security and reliability of CUSTOMBONE cranioplasties: A prospective multicentric study.

BACKGROUND: Repairing bone defects generated by craniectomy is a major therapeutic challenge in terms of bone consolidation as well as functional and cognitive recovery. Furthermore, these surgical procedures are often grafted with complications such as infections, breaches, displacements and rejections leading to failure and thus explantation of the prosthesis. OBJECTIVE: To evaluate cumulative explantation and infection rates following the implantation of a tailored cranioplasty CUSTOMBONE prosthesis made of porous hydroxyapatite. One hundred and ten consecutive patients requiring cranial reconstruction for a bone defect were prospectively included in a multicenter study constituted of 21 centres between December 2012 and July 2014. Follow-up lasted 2 years. RESULTS: Mean age of patients included in the study was 42±15 years old (y.o), composed mainly by men (57.27%). Explantations of the CUSTOMBONE prosthesis were performed in 13/110 (11.8%) patients, significantly due to infections: 9/13 (69.2%) (p<0.0001), with 2 (15.4%) implant fracture, 1 (7.7%) skin defect and 1 (7.7%) following the mobilization of the implant. Cumulative explantation rates were successively 4.6% (SD 2.0), 7.4% (SD 2.5), 9.4% (SD 2.8) and 11.8% (SD 2.9%) at 2, 6, 12 and 24 months. Infections were identified in 16/110 (14.5%): 8/16 (50%) superficial and 8/16 (50%) deep. None of the following elements, whether demographic characteristics, indications, size, location of the implant, redo surgery, co-morbidities or medical history, were statistically identified as risk factors for prosthesis explantation or infection. CONCLUSION: Our study provides relevant clinical evidence on the performance and safety of CUSTOMBONE prosthesis in cranial procedures. Complications that are difficulty incompressible mainly occur during the first 6 months, but can appear at a later stage (>1 year). Thus assiduous, regular and long-term surveillances are necessary.

Covered vs bare stent for distal malignant biliary obstruction due to primary common biliary cancer.

ABSTRACT: This study was designed as a means of comparing the clinical efficacy and long-term outcomes of covered vs bare stent insertion as a treatment for distal malignant biliary obstruction (DMBO) caused by primary common biliary cancer (PCBC).This retrospective study was designed using data collected between January 2012 and December 2019 to assess the short- and long-term outcomes in patients with DMBO caused by PCBC treated by inserting either bare or covered stents were compared.Ninety two patients with DMBO caused by PCBC were divided between bare (n = 51) or covered (n = 41) stent groups. Technical success rates in both groups were 100%. Clinical success of bare vs covered stent use were 96.1% and 97.6% (P = 1.00). Stent dysfunction was seen in 17 and 6 patients in the bare and covered stent groups, respectively (P = .04). The median stent patency for bare and covered stents was 177 and 195 days, respectively (P = .51). The median survival was 188 and 200 days in the bare and covered stent groups, respectively (P = .85).For patients with DMBO caused by PCBC, using bare vs covered stents yields similar clinical efficacy and long term outcomes.

Society of Interventional Radiology Clinical Practice Guideline for Inferior Vena Cava Filters in the Treatment of Patients with Venous Thromboembolic Disease: Developed in collaboration with the American College of Cardiology, American College of Chest Physicians, American College of Surgeons Committee on Trauma, American Heart Association, Society for Vascular Surgery, and Society for Vascular Medicine.

PURPOSE: To provide evidence-based recommendations on the use of inferior vena cava (IVC) filters in the treatment of patients with or at substantial risk of venous thromboembolic disease. MATERIALS AND METHODS: A multidisciplinary expert panel developed key questions to address in the guideline, and a systematic review of the literature was conducted. Evidence was graded based on a standard methodology, which was used to inform the development of recommendations. RESULTS: The systematic review identified a total of 34 studies that provided the evidence base for the guideline. The expert panel agreed on 18 recommendations. CONCLUSIONS: Although the evidence on the use of IVC filters in patients with or at risk of venous thromboembolic disease varies in strength and quality, the panel provides recommendations for the use of IVC filters in a variety of clinical scenarios. Additional research is needed to optimize care for this patient population.

Ureteral stents: the good the bad and the ugly.

PURPOSE OF REVIEW: Ureteral stents are necessary in the routine practice of an urologist. Choosing the correct stent and being aware of the options available will allow urologists to provide the best possible care for patients and value to the healthcare system. This review seeks to educate urologists regarding improvements in stent technology currently available or in development. RECENT FINDINGS: Research from around the world is underway to discover an ideal stent - one that is comfortable for patients, resists infection and encrustation and is affordable for hospital systems. Stent design alterations and stent coatings are revealing reductions in encrustation and bacterial colonization. Biodegradable stents and magnetic stents are being tested to prevent the discomfort of cystoscopic removal. Intraureteral stents are proving efficacious while eliminating an irritating coil from the bladder and the symptoms associated with it. SUMMARY: The studies highlighted in this review provide encouraging results in the pursuit of the ideal stent while opening discussion around new concepts and further areas of research.

Training and Transfer Effect of FluoroSim, an Augmented Reality Fluoroscopic Simulator for Dynamic Hip Screw Guidewire Insertion: A Single-Blinded Randomized Controlled Trial.

BACKGROUND: FluoroSim, a novel fluoroscopic simulator, can be used to practice dynamic hip screw (DHS) guidewire insertion in a high-fidelity clinical scenario. Our aim was to demonstrate a training effect in undergraduate medical students who are not familiar with this operation and its simulation. METHODS: Forty-five undergraduate medical students were recruited and randomized to either training (n = 23) or control (n = 22) cohorts. The training cohort had more exposure to FluoroSim (5 attempts each week) over a 2-week period (with a 1-week washout period in between) compared with the control cohort (a single attempt 1 week apart) over a 2-week period. Five real-time objective performance metrics were recorded: (1) tip-apex distance (TAD) (mm), (2) predicted cut-out rate (%), (3) total procedural time (sec), (4) total number of radiographs (n), and (5) total number of guidewire retries (n). RESULTS: At baseline, there was no significant difference in the performance metrics, which confirmed the absence of a selection bias. The intragroup training effect demonstrated a significant improvement in all metrics for the training cohort only. A significant difference between groups was demonstrated as the training cohort significantly outperformed the control cohort in 3 metrics (procedural time [25%], number of radiographs [57%], and number of guidewire retries [100%]; p < 0.001). A learning curve showed an inversely proportional correlation between frequency of attempts and procedural time as well as the number of digital fluoroscopic radiographs that were made, indicating the development of psychomotor skills. There was also an improved baseline of the learning curve after the 1-week washout period, suggesting skill retention. CONCLUSIONS: Skill acquisition with the FluoroSim system was demonstrated with repeat exposure in a safe, radiation-free high-fidelity clinical simulation with actual operating room equipment. The task of DHS guidewire insertion requires cognitive and psychomotor skills that take a variable number of attempts to acquire, as demonstrated on the learning curve. Additional work is required to demonstrate that the skill tested by the FluoroSim is the same skill that is required for intraoperative DHS guidewire insertion. However, use of the FluoroSim provides improvement in skills with extra-clinical training opportunities for orthopaedic trainees. CLINICAL RELEVANCE: FluoroSim has demonstrated validity and training effect. It has the potential to be approved for possible use on patients in the operating room to help surgeons with the operation. Consequently, operating time, accuracy of TAD, and surgical outcomes may all be improved.

Radiographic assessment of overlengthening of the MoPyC radial head prosthesis: a cadaveric study.

INTRODUCTION: The aim of this study was to evaluate a radiographic measurement method for assessment of overlengthening of the MoPyC radial head prosthesis. MATERIALS AND METHODS: Seven cadaver specimens were studied in ten stages: native specimen (1), radial head resection (2), and implantation of the MoPyC radial head prostheses (Bioprofile, Tornier, Montbonnot-Saint-Martin, France) in four increasing length (correct length, overlengthening of 1.5 mm, 3 mm, and 5 mm) with an intact medial collateral ligament (MCL 3-6) and following transection of the MCL (7-10). The radiographic measurement method according to Athwal et al. was evaluated to detect overlengthening. Statistical analysis included calculation of the diagnostic accuracy of the radiographic method. RESULTS: The radiographic measurement method correctly determined the size of the radial head prosthesis within ± 1 mm in 224 of 336 scenarios (67%) and within ± 2 mm in 320 of 336 scenarios (95%). With a threshold value of ≥ 1 mm, the overall diagnostic sensitivity for detecting overlengthening when it was present and was 90% and the specificity was 79%. The sensitivity was higher with increasing size of the prosthesis: in cases with overlengthening of 1.5 mm, the sensitivity was 76%, with an overlengthening of 3 mm, the sensitivity was 95%, and with an overlengthening of 5 mm, the sensitivity was 100%. CONCLUSION: The radiographic measurement method of Athwal et al. can be used to estimate and to diagnose the magnitude overlengthening of the MoPyC radial head prosthesis. However, the sensitivity is limited (76%) in cases with a small amount of overlengthening of 1.5 mm.

A Pilot Study Comparing 2- and 3-dimensional Ultrasound Imaging for Confirmation of Essure Fallopian Tube Pregnancy Prevention Implants.

STUDY OBJECTIVE: To show the feasibility of 2-dimensional (2D) ultrasound (US) imaging compared with 3-dimensional (3D) US to identify the location of implants and assess if the classification developed by Simorre et al in 2016 was applicable to the 2 types of US imaging (i.e., 2D and 3D). DESIGN: A prospective study (Canadian Task Force classification II-2). SETTING: The department of obstetrics and gynecology in a teaching hospital. PATIENTS: One hundred fifty patients who had undergone hysteroscopic sterilization with Essure (Bayer Pharma AG Laboratory, Lyon, France) fallopian tube pregnancy prevention implants were invited by letter to participate in the study; 50 replied positively between January and August 2017. INTERVENTIONS: An initial 2D US was performed followed by 3D US reconstruction. The primary end point was to compare the identification of device placement with 2D and 3D US imaging procedures according to this new classification. Secondary considerations were to evaluate the difficulty of attaining images, the quality of implant curvature, the duration of each imaging procedure, and the number of images performed for each technique. MEASUREMENTS AND MAIN RESULTS: Ninety-six percent of tubal implants were observed via 3D US compared with 100% via 2D US. The mean time of 2D US was 14.64 seconds for the right fallopian tube and 15.25 seconds for the left fallopian tube compared with 25.11 seconds for the right and 31.57 seconds for the left fallopian tube in 3D US (p <.01). The mean number of image acquisitions per patient was 1.02 (±0.14 standard deviation) for 2D US compared with 1.37 (±0.64 standard deviation) for 3D US (p <.01). The sonographer had no difficulty performing 2D US in 88% of cases compared with 58% of 3D US cases. CONCLUSIONS: Two-dimensional ultrasound appears to be an acceptable alternative to 3D US. We propose a 2D classification for cross section device localization to facilitate image interpretation.

Direct comparison of the novel automated screening tool (AST) versus the manual screening tool (MST) in patients with already implanted subcutaneous ICD.

BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (S-ICD) has evolved as a valuable alternative to the transvenous ICD, especially in young patients. Unfortunately, some of these patients are ineligible for S-ICD implantation due to specific electrocardiographic features. So far, these patients were identified by mandatory pre-implantation screening using the manual screening tool (MST), which lacks objective value. Therefore, a novel automated screening tool (AST) has been introduced recently for objective screening, which has not been evaluated yet. METHODS/RESULTS: We here first investigate the novel AST, in direct comparison to MST, in 33 consecutive patients with already implanted S-ICD system to compare predicted eligibility by screening tools with true sensing of the S-ICD system. Both screening tools reliably predicted true ineligible single vectors, but also suggested overall ineligibility in a similar fraction of patients (MST: 3.0%; AST: 6.1%), albeit the implanted S-ICD worked flawlessly in these patients. AST did not predict the finally selected sensing vector better than MST. There was a surprising mismatch between AST and MST for the predicted eligibility of single vectors; only in 49% of patients did both screening tools predict eligibility for the same vectors. CONCLUSIONS: The novel AST predicted overall eligibility approximately similar to MST. Both tools predicted ineligibility in a few patients, who were actually eligible. There was a striking mismatch between both screening tools when eligibility of single vectors was predicted. Thus, the AST seems to be a valuable advance, due to its standardized and objective process, but it still lacks specificity.

Accuracy of screw fixation using the O-arm® and StealthStation® navigation system for unstable pelvic ring fractures.

PURPOSE: Screw fixation for unstable pelvic ring fractures is generally performed using the C-arm. However, some studies reported erroneous piercing with screws, nerve injuries, and vessel injuries. Recent studies have reported the efficacy of screw fixations using navigation systems. The purpose of this retrospective study was to investigate the accuracy of screw fixation using the O-arm® imaging system and StealthStation® navigation system for unstable pelvic ring fractures. METHODS: The participants were 10 patients with unstable pelvic ring fractures, who underwent screw fixations using the O-arm StealthStation navigation system (nine cases with iliosacral screw and one case with lateral compression screw). We investigated operation duration, bleeding during operation, the presence of complications during operation, and the presence of cortical bone perforation by the screws based on postoperative CT scan images. We also measured the difference in screw tip positions between intraoperative navigation screen shot images and postoperative CT scan images. RESULTS: The average operation duration was 71 min, average bleeding was 12 ml, and there were no nerve or vessel injuries during the operation. There was no cortical bone perforation by the screws. The average difference between intraoperative navigation images and postoperative CT images was 2.5 ± 0.9 mm, for all 18 screws used in this study. CONCLUSION: Our results suggest that the O-arm StealthStation navigation system provides accurate screw fixation for unstable pelvic ring fractures.

Osseointegrated Transtibial Implants in Patients with Peripheral Vascular Disease: A Multicenter Case Series of 5 Patients with 1-Year Follow-up.

BACKGROUND: Osseointegration is an alternative treatment for amputees who are unable to wear or have difficulty wearing a socket prosthesis. Although the majority of limb amputations are due to vascular disease, such amputations have been perceived as a contraindication to osseointegration surgery. We report the outcomes of osseointegrated reconstruction in a series of 5 patients with limb amputation due to peripheral vascular disease. METHODS: Five patients with transtibial amputation and a history of peripheral vascular disease who received an osseointegration implant from 2014 to 2015 were followed for 12 months. Clinical and functional outcomes were assessed, including pain, the amount of time the patient wore the prosthesis, mobility, walking ability, and quality of life. Adverse events, including infection, fracture, implant failure, revision surgery, additional amputation, and death, were monitored and recorded. RESULTS: Five transtibial amputees (56 to 84 years of age) followed for 1 year after osseointegration surgery were included in this case series. The mobility of all patients was improved at the time of follow-up. Three patients were wheelchair-bound prior to the surgery but all 5 were able to walk and perform daily activities at the time of follow-up. Four of the 5 patients were pain-free at 12 months postoperatively, and all 5 were using the osseointegrated prosthesis. Two patients had a single episode of superficial soft-tissue infection. CONCLUSIONS: An osseointegrated implant may be considered a feasible alternative to the conventional socket prosthesis for patients with peripheral vascular disease. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Staying away from the optic nerve: a formula for modifying glaucoma drainage device surgery in pediatric and other small eyes.

PURPOSE: To provide guidelines for safe implantation of glaucoma drainage devices (GDDs) in small and pediatric eyes to avoid contact between the optic nerve (ON) and the posterior edge of the GDD plate. METHODS: We developed a formula for calculating limbus-to-ON distance to estimate the available "real estate" for GDD placement in small eyes. The formula was validated using eyes of pediatric decedents undergoing clinical autopsy, with axial lengths (AL) of 15-24 mm. For each autopsy eye, we measured AL, anterior chamber depth, corneal diameter, and limbus-to-ON distances for the four eye quadrants. The main outcome measure was the degree of agreement between measured and calculated limbus-to-ON distances. RESULTS: A total of 15 autopsy eyes were divided into derivation (n = 10) and validation (n = 5) groups. A formula was derived to estimate superotemporal limbus-to-ON distance (DST) using AL and corneal diameter data. Linear regression showed excellent correlation between the measured DST and AL (R2 = 0.98). There was excellent agreement between measured and calculated limbus-to-ON values for all four eye quadrants (R2 range, 0.92-0.98). CONCLUSIONS: Our formula accurately predicts limbus-to-ON distances across a wide range of clinically relevant ALs. Based on this information, GDD surgery in small eyes can be adjusted by positioning the GDD closer to the limbus or by trimming the posterior edge of the GDD plate. To our knowledge, this is the first set of guidelines developed to promote safe implantation of GDDs in small eyes.

Indications and contraindications: interspinous process decompression devices in lumbar spine surgery.

BACKGROUND: Interspinous process decompression devices (IPD) allow a minimally invasive treatment of lumbar spinal stenosis (LSS), but their use is discussed highly controversial. Several level I studies suggest that IPD implantation is a viable alternative for both conservative treatment and decompression, but clear indications and contraindications are still missing. This study was designed to explore the perspectives and limitations of IPDs and to evaluate the role of these devices in general. MATERIAL AND METHODS: The study is based on a questionnaire sent to all hospitals registered in the German Hospital Address Register 2010 with an orthopedic, neurosurgerical, or spine surgery department (n = 1,321). The questionnaire was reviewed by experienced spine surgeons and statisticians, and included both single-response, close-ended, and multiple-response open-ended questions. RESULTS: We received 329 (24.9%) entirely analyzable questionnaires. A total of 164 respondents (49.8%) stated that IPDs are a treatment option for LSS, and 135 of the 164 respondents (82.3%) use them. Poor clinical experience (60%) and lack of evidence (53.9%) are the main reasons cited for not using IPDs. We detected a high negative correlation between the size of the hospital, the number of outpatients and inpatients treated for LSS and other spine pathologies, and the use of IPDs (p = 0.001). Most respondents prefer the combination of open decompression and IPD (64.4%; n = 87). A total of 9.6% (n = 13) of the users favor IPD implantation as a stand-alone procedure. Overall, 25.9%  n = 35 use both options. Most surgeons aim to relieve the facet joints (87.7%) and to stabilize a preexisting instability (75.4%). They recommend IPDs in the segments L2-L3 (77%), L3-L4 (98.5%), and L4-l5 (99.3%) and consider that IPD implanation also could be done at the L5-S1 segment (40.1%). Overall, 64.4% (n = 87) of the users recommend limiting IPD implantation to two segments. Infection (96.3%), fracture (94.8%), isthmic spondylolisthesis (77%), degenerative spondylolisthesis (higher than Meyerding I [57%]), lumbar spine scoliosis (48.1%), and osteoporosis (50.4%) are seen as contraindications for IPD. CONCLUSION: No clear consensus exists among spine surgeons concerning the use of IPD for LSS treatment. The study showed that hospital-related parameters also influence decision making for or against the use of IPDs. However, despite the lack of evidence, the indications and contraindications which had been identified in the present study might contribute to improved outcomes after IPD implantation or at least prevent harm to patients.

Learning curve of 3D fluoroscopy image-guided pedicle screw placement in the thoracolumbar spine.

BACKGROUND CONTEXT: During the past decade, a disproportionate increase of spinal fusion procedures has been observed. Along with this trend, image-guided spine surgery has been experiencing a renaissance in the recent years. A wide range of different navigation systems are available on the market today. However, only few published studies assess the learning curves concerning these new spinal navigation techniques. So far, a study on the learning curve for intraoperative three-dimensional fluoroscopy (3DFL)-navigated pedicle screw (PS) placement is still lacking. PURPOSE: The purpose of the study was to analyze the learning curve for 3DFL-navigated thoracolumbar PS placement. STUDY DESIGN/SETTING: The study design included a prospective case series. PATIENT SAMPLE: A cohort of 145 patients were recruited from January 2011 to June 2012. OUTCOME MEASURES: The outcome measures were duration of intraoperative 3D scans, PS placement, PS accuracy on postoperative computed tomography (CT) scans, and PS-related revisions and complications. METHODS: From the introduction of spinal navigation to our department in January 2011 until June 2012, the learning curve for the duration of intraoperative 3D scan acquisition (navigation or control scan) and placement time per screw, intraoperative screw revisions, screw-related complications, revision surgeries, and PS accuracy on postoperative CT scans were assessed in 145 patients undergoing dorsal navigated instrumentation for 928 PS (736 lumbosacral and 192 thoracic). The observed time span was divided into four intervals. Results of the second, third, and last periods were compared with the first (reference) period, respectively. RESULTS: The mean navigation 3D scan time decreased (first and fourth periods) from 15.4±7.8 (range, 4-40) to 8.4±3.3 (3-15) minutes (p<.001). The mean control 3D scan time (after PS placement) decreased from 11.2±4.8 (5-25) to 6.6±3.0 (3-15) minutes (p<.001). The mean PS insertion time decreased from 5.3±2.5 (1-15) to 3.2±2.3 (1-17) minutes (p<.001). The mean proportion of correctly positioned PS (all 928) according to the Gertzbein and Robbins classification grades A and B increased initially from 83.1% (first period) to 95.1% (second period, p=.001), 96.4% (third period, p=.002), and 92.4% (fourth period, p=.049). No learning effect was found with respect to intraoperative screw revisions. There was one revision surgery. CONCLUSIONS: We could demonstrate significant learning effects for 3DFL-navigated PS placement with regard to intraoperative 3D scan acquisition, PS placement time, and PS accuracy.

Practical ways to reduce radiation dose for patients and staff during device implantations and electrophysiological procedures.

Despite the advent of non-fluoroscopic technology, fluoroscopy remains the cornerstone of imaging in most interventional electrophysiological procedures, from diagnostic studies over ablation interventions to device implantation. Moreover, many patients receive additional X-ray imaging, such as cardiac computed tomography and others. More and more complex procedures have the risk to increase the radiation exposure, both for the patients and the operators. The professional lifetime attributable excess cancer risk may be around 1 in 100 for the operators, the same as for a patient undergoing repetitive complex procedures. Moreover, recent reports have also hinted at an excess risk of brain tumours among interventional cardiologists. Apart from evaluating the need for and justifying the use of radiation to assist their procedures, physicians have to continuously explore ways to reduce the radiation exposure. After an introduction on how to quantify the radiation exposure and defining its current magnitude in electrophysiology compared with the other sources of radiation, this position paper wants to offer some very practical advice on how to reduce exposure to patients and staff. The text describes how customization of the X-ray system, workflow adaptations, and shielding measures can be implemented in the cath lab. The potential and the pitfalls of different non-fluoroscopic guiding technologies are discussed. Finally, we suggest further improvements that can be implemented by both the physicians and the industry in the future. We are confident that these suggestions are able to reduce patient and operator exposure by more than an order of magnitude, and therefore think that these recommendations are worth reading and implementing by any electrophysiological operator in the field.

Scientific evaluation and pricing of medical devices and associated procedures in France.

Medical devices are many and various, ranging from tongue spatulas to implantable or invasive devices and imaging machines; their lifetimes are short, between 18 months and 5 years, due to incessant incremental innovation; and they are operator-dependent: in general, the clinical user performs a fitting procedure (hip implant or pacemaker), a therapeutic procedure using a non-implantable invasive device (arrhythmic site ablation probe, angioplasty balloon, extension spondyloplasty system, etc.) or follow-up of an active implanted device (long-term follow-up of an implanted cardiac defibrillator or of a deep brain stimulator in Parkinson's patients). A round-table held during the XXVIII(th) Giens Workshops meeting focused on the methodology of scientific evaluation of medical devices and the associated procedures with a view to their pricing and financing by the French National Health Insurance system. The working hypothesis was that the available data-set was sufficient for and compatible with scientific evaluation with clinical benefit. Post-registration studies, although contributing to the continuity of assessment, were not dealt with. Moreover, the focus was restricted to devices used in health establishments, where the association between devices and technical medical procedures is optimally representative. An update of the multiple regulatory protocols governing medical devices and procedures is provided. Issues more specifically related to procedures as such, to non-implantable devices and to innovative devices are then dealt with, and the proposals and discussion points raised at the round-table for each of these three areas are presented.

[GSTCVS certificate for cardiac pacemaker, ICD and CRT therapy]. / DGTHG-Zertifizierung zur Herzschrittmacher-, ICD- und CRT-Therapie.

Medical qualifications to perform operations with cardiac electronic implantable devices as well as for preoperative and postoperative therapy, including follow-up in this patient population are not well defined. Based on recommendations which have been worked out and published by an interdisciplinary consensus of cardiac surgeons, cardiologists and electrophysiologists, a certificate with three modules has been developed by the Working Group for Electrophysiologic Surgery of the German Society for Thoracic and Cardiovascular Surgery (GSTCVS, Deutsche Gesellschaft für Thorax-, Herz- und Gefäßchirurgie, DGTHG). First examinations for this certificate will be held in 2013 and transitional regulations apply until 1st April 2014. Further details are available on the homepage of the GSTCVS.

Percutaneous interspinous spacer versus open decompression: a 2-year follow-up of clinical outcome and quality of life.

PURPOSE: Percutaneous interspinous stand-alone spacers offer a simple and effective technique to treat lumbar spinal stenosis with neurogenic claudication. Nonetheless, open decompressive surgery remains the standard of care. This study compares the effectiveness of both techniques and the validity of percutaneous interspinous spacer use. METHODS: Forty-five patients were included in this open prospective non-randomized study, and treated either with percutaneous interspinous stand-alone spacers (Aperius(®)) or bilateral open microsurgical decompression at L3/4 or L4/5. Patient data, operative data, COMI, SF-36, PCS and MCS, ODI, and walking distance were collected 6 weeks, 3, 6, 9, 12, and 24 months post-surgery. RESULTS: Group 1 (n = 12) underwent spacer implantation, group 2 (n = 33) open decompression. Five patients from group 1 required implant removal and open decompression during follow-up (FU); one patient was lost to FU. From group 2, seven patients were lost to FU. Remaining patients were assessed as above. After 2 years, back pain, leg pain, ODI, and quality of life improved significantly for group 2. Remaining group 1 patients (n = 6) reported worse results. Walking distance improved for both groups. CONCLUSION: Decompression proved superior to percutaneous stand-alone spacer implantation in our two observational cohorts. Therapeutic failure was too high for interspinous spacers.

Evaluation of quality indices during multifractionated pelvic interstitial brachytherapy for cervical cancer.

PURPOSE: To evaluate the impact of needle displacements on quality indices during multifractionated pelvic interstitial brachytherapy (IBT). METHODS AND MATERIALS: Patients undergoing boost IBT were included. Postprocedure planning and verification CT scans were obtained. Three-dimensional needle displacements were measured. Clinical target volume and organ at risk were delineated. Coverage index (CI), dose homogeneity index (DHI), dose nonuniformity ratio (DNR), V170, V200, V250, and dose received by 2cc of organs at risk were obtained at baseline. The displacements were simulated by shifting dwell positions, and dose point optimized and graphically optimized plans were generated. Wilcoxon test determined statistical significance of differences in quality indices. RESULTS: Fifteen patients were included and received five fractions of IBT over 3 days. Maximum displacements were observed in caudal direction (average, 19.1mm). At baseline, CI of 0.94 (range, 0.91-0.99), DHI of 0.90 (range, 0.80-0.94), and DNR of 0.10 (range, 0.05-0.10) were attained. The CI, DHI, and DNR in Day 3 dose point optimized plans were 0.76 (range, 0.4-0.99), 0.76 (range, 0.40-0.94), and 0.23 (range, 0.06-0.64), respectively. The difference in CI, DHI, and DNR between baseline and Day 3 dose point optimized plans was statistically significant (p = 0.002, 0.007, and 0.001, respectively). Day 3 graphically optimized plans were superior to Day 3 dose point optimized plans (CI, 0.82 vs. 0.76; p = 0.01). Graphically optimized could however improve CI without compromise in DHI, DNR, V170, V200, and V250 only in patients wherein caudal displacements ≤15mm. CONCLUSIONS: Caudal needle displacements during multifractionated IBT cause significant deterioration of quality indices. Replanning with graphically optimized and/or needle repositioning maybe required for maintaining the quality of IBT.